Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity

NCT05014763 | Unknown

• 1 other identifier: 9811213001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.

Conditions

Alveolar Ridge Augmentation; Tissue Transplantation; Tissue Donors

Outcome Measures

Primary Outcomes (3)

• soft tissue volume change 0-3

  changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner

  from baseline (immediately before surgery) to 3 months

• soft tissue volume change 0-6

  changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner

  from baseline (immediately before surgery) to 6 months

• soft tissue volume change 3-6

  changes of soft tissue volume from 3 months to 6 months by intra oral scanner

  from 3 months to 6 months

Secondary Outcomes (11)

• The level of the pain by questionnaire through visual analogue scale

  immediately after surgery

• The level of the pain by questionnaire through visual analogue scale

  day 1

• The level of the pain by questionnaire through visual analogue scale

  day 2

• The level of the pain by questionnaire through visual analogue scale

  day 3

• The level of the pain by questionnaire through visual analogue scale

  day 4

Study Arms (2)

CTG from deep palate

ACTIVE COMPARATOR

The connective tissue graft harvested from the deep palate during flap elevation for implant placement

Procedure: connective tissue graft

CTG from tuberosity

EXPERIMENTAL

The connective tissue graft harvested from the tuberosity

Procedure: connective tissue graft

Interventions

connective tissue graft PROCEDURE

Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.

CTG from deep palate; CTG from tuberosity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• more than 18 years old.
• systemically and periodontally healthy patients.
• need of single implant placement between two maxillary teeth.
• need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
• more than 3 month after extraction.
• full mouth plaque index lesser than 20%.
• sufficient mesiodistal and buccolingual space.
• At least 10 millimetres mesiodistal dimension in tuberosity.
• sufficient implant primary stability.
• at least 6 mm crestal ridge width.

You may not qualify if:

• History of periodontitis and radiotherapy.
• Need of horizontal ridge augmentation.
• Previous soft tissue augmentation.
• Heavy smoker( more than 10 cigarette per day)
• Local or systemic conditions that would interfere with routine periodontal therapy.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

Study Officials

• Neda Moslemi, Periodontist

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neda Moslemi, Periodontist

CONTACT

+989128985838; neda_moslemi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 20, 2021
• Study Start: September 20, 2021
• Primary Completion: September 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)